Can hyperbaric oxygen be used to cure for Long COVID? A clinical trial.

Phase 1

• Conditions: ong COVID, post-acute COVID-19 Syndrome, post COVID-19 Syndrome (ICD-10 U09.0); MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: PTClassification code 10057244Term: Post viral fatigue syndromeSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10063080Term: Postural orthostatic tachycardia syndromeSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2021-000764-30-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-28
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1)Aged 18–60 years
2)Healthy or mild systemic disease prior to COVID-19
3)Symptoms consistent with Long COVID for at least 12 weeks
4)Diagnosed with Long COVID, PACS, PCS (ICD-10 U09.9)
5)Working or studying prior to COVID-19
6)Documented informed consent according to ICH-GCP and national regulations

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Known pregnancy or positive pregnancy test in women of childbearing age
2)ASA 3 or more from other cause than Long COVID
3)Score above 70 in RAND-36 domain Role Limitation Physical Health (RP) or Physical Functioning (PF)
4)Diabetes
5)Diagnosed with Hypertension prior to COVID-19
6)Contraindication for HBO2 treatment according to local guidelines
7)Participation or recent participation in a clinical trial with an investigational product
8)Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of trialstudy participation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified